Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma

• Published in: European journal of cancer (1990) 2011-06, Vol.47 (9), p.1287-1298
• Main Authors: Porta, Camillo, Osanto, Susanne, Ravaud, Alain, Climent, Miguel-Angel, Vaishampayan, Ulka, White, Dorothy A, Creel, Patricia, Dickow, Brenda, Fischer, Patricia, Gornell, Suzanne Sweeney, Meloni, Federica, Motzer, Robert J
• Format: Article
• Language: English
• Subjects: Adverse events; Aged; Biological and medical sciences; Carcinoma, Renal Cell - drug therapy; Clinical Trials as Topic; Disease Progression; Everolimus; Hematology, Oncology and Palliative Medicine; Humans; Immunosuppressive Agents - therapeutic use; Liver Neoplasms - drug therapy; Male; Medical sciences; Middle Aged; Neoplasm Metastasis; Patient management; Pharmacology. Drug treatments; Placebos; Pneumonia - drug therapy; Randomized Controlled Trials as Topic; Renal cell carcinoma; Research Design; Risk; Safety; Sirolimus - adverse effects; Sirolimus - analogs & derivatives; Stomatitis - chemically induced; Time Factors; Treatment Outcome; Tumors
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2011.02.014

Abstract Purpose In April 2009, an expert group of 11 physicians and clinical nurses met to discuss the management of selected adverse events associated with the use of everolimus for the treatment of metastatic renal cell carcinoma (mRCC). Everolimus is an orally administered inhibitor of the mammalian target of rapamycin that recently received approval from the European Medicines Agency for the treatment of advanced RCC that has progressed on or after treatment with vascular endothelial growth factor (VEGF)–targeted therapy, and from the United States Food and Drug Administration for treatment of advanced RCC after failure of sorafenib or sunitinib. Before the approval of everolimus, no standard therapy existed for the treatment of mRCC after failure of VEGF-targeted therapy. RECORD-1 ( R enal C ell cancer treatment with O ral R AD001 given D aily) was the pivotal multicenter, phase III, randomised, double-blind, placebo-controlled trial of everolimus that led to approval for patients with disease progression on or after treatment with VEGF-targeted agents. Safety data from RECORD-1 were reviewed by these clinicians, all of whom had experience using everolimus in patients with mRCC. Adverse events discussed were non-infectious pneumonitis, infections, stomatitis and metabolic abnormalities. Results The outcome of this discussion is summarised here. Guidance for management of these adverse events is provided. Both clinicians and patients should be aware of the potential side-effects of everolimus and understand that these side-effects are manageable with standard care to optimise patient benefit.